[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Proteocyte Diagnostics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":23,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100504857",false,"NCT05853783","Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™","Inclusion Criteria:\n\n* From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system)\n* Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:\n* No histological evidence of cancer with clinical follow-up data for a period of at least five years; or\n* OSCC development (histologic or documented evidence of invasive cancer).\n* Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center.\n\nExclusion Criteria:\n\n* Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients.\n* Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.","ALL","18 Years",{"count":17,"type":18},180,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.",[22],"Mouth Diseases",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Leukoplakia","Erythroplakia","Erythroleukoplakia","Lesion","Oral epithelial dysplasia","S100A7 biomarker","S100A7 Immunohistochemistry Signature-based","Early Diagnosis","STRATICYTE","Oral neoplasia","Oral epithelial atypia","Hyperplasia","Hyperkeratosis","Potentially premalignant oral epithelial lesion","Oral potentially malignant disorders","Mild dysplasia","Moderate dysplasia","Severe dysplasia","Low-grade dyspalsia","High-grade dysplasia","Personalized medicine","Predictive Assay","Whole slide imaging","Computational pathology","Digital pathology","Oral potentially malignant lesion","RECRUITING","2024-11-05",{"date":53,"type":54},"2024-11-07","ACTUAL",{"date":56,"type":54},"2023-01-01",{"date":58,"type":18},"2024-12",{"name":60,"class":61},"Proteocyte Diagnostics Inc.","INDUSTRY",5,{"id":64,"slug":4,"hasResults":10,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":10,"sex":14,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100410281","NCT04622462","Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment","A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE","Inclusion Criteria:\n\n* Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia\u002Foral squamous cell carcinoma\n\nExclusion Criteria:\n\n* Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy","15 Years","90 Years",{"count":72,"type":18},500,"The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.",[75],"Oral Neoplasm",[24,25,26,27,77,78,30,31,32,79,80,35,36,81,82,83,84,85,86,87,88,89,90,45,91,92,93,94,95,96,97,98],"Oral Epithelial Dysplasia","S100A7 Biomarker","Oral Neoplasia","Oral Epithelial Atypia","Oral Squamous Cell Carcinoma","Oral Cancer","Potentially Premalignant Oral Epithelial Lesion","OPMD","Mild Dysplasia","Moderate Dysplasia","Severe Dysplasia","Low-grade Dysplasia","High-grade Dysplasia","Personalized Medicine","Whole Slide Imaging","Computational Pathology","Digital Pathology","Artificial Intelligence","Machine Learning","OPML","Oral Potentially Malignant Disorder","Oral Potentially Malignant Lesion",{"date":53,"type":54},{"date":101,"type":54},"2015-03-12",{"date":103,"type":18},"2026-12-31",{"name":60,"class":61},3,""]